Dr. Vinay Prasad

Role status — October 2026: Prasad directed the FDA’s Center for Biologics Evaluation and Research from May 2025 to April 2026 — a tenure that included a brief resignation and reinstatement in mid-2025 — and has returned to UCSF.

Vinay Prasad is an American hematologist-oncologist, researcher, writer, and — in 2025–26 — director of the FDA’s Center for Biologics Evaluation and Research. He completed his medical degree at the University of Chicago in 2009, an internal-medicine residency at Northwestern University in 2012, a Master of Public Health from Johns Hopkins University in 2014, and a joint fellowship in oncology at the National Cancer Institute and hematology at the National Heart, Lung, and Blood Institute in 2015.

From 2015 to 2020, Prasad was assistant and then associate professor at Oregon Health & Science University. He then moved to the University of California, San Francisco, where he became a full professor of hematology-oncology and built a research program focused on how oncology drugs are approved, what endpoints are used in pivotal trials, and how the evidence base behind those approvals shifts over time.

His academic work is most closely associated with the concept of medical reversal — the phenomenon of an established medical practice being contradicted by later, higher-quality evidence. The 2015 book Ending Medical Reversal, co-authored with Adam Cifu, coined the term and gave it scholarly footing. Malignant (2020) applied the same lens to oncology approvals, particularly the accelerated-approval pathway and the frequent use of surrogate endpoints.

During the COVID-19 pandemic, Prasad became a prominent public commentator on school closures, cloth masking in pediatric populations, and the evidence base for booster recommendations in low-risk groups. Those positions put him into recurring conflict with more cautious public-health voices and built a large independent audience. He runs a substack newsletter and co-edits Sensible Medicine, a publication launched with a group of peers who shared concerns about the direction of pandemic-era medical commentary.

In 2025, Prasad left his UCSF professorship to direct the FDA’s Center for Biologics Evaluation and Research. He departed at the end of April 2026 and returned to UCSF; his status dot is yellow on this site as he resumes public commentary from outside the agency.

Inside the MAHA coalition, Prasad occupies a unique seat. Much of the coalition’s rhetoric on FDA accelerated-approval reform, evidence-standards tightening, and medical-reversal awareness traces through his published work. His physical presence inside the FDA is therefore more consequential than his public-commentary footprint alone.

Current battles include learning to operate inside the agency’s regulatory-process culture, balancing continued public writing with federal-employee communication constraints, and navigating his relationships with former academic and journalistic allies who are now, in effect, writing about him from the outside.

Open questions: whether his FDA role is formalized into a specific senior post, whether he publicly weighs in on any specific oncology drug review while at the agency, and whether his tenure inside FDA produces concrete rulemaking on surrogate endpoints and accelerated-approval confirmation studies.

Update (2026-05-04): Prasad departed CBER at the end of April 2026, concluding what FDA Commissioner Marty Makary characterized as a planned one-year leave of absence from his UCSF faculty post. Katherine Szarama, Prasad’s deputy, has been named acting director of CBER.